Collects adverse event data on all marketed products and those in development. Implements and oversees adverse event processes and databases. Ensures regulatory compliance for both expedited and periodic reports. Provides integrated strategic safety expertise to clinical development programs. Performs active pharmacovigilance with rapid identification and analysis of safety signals to define emerging drug safety profiles of all products and drive patient risk management. Delivers high-quality product safety data and analysis to internal and external customers throughout the product life cycle.
Education
Advanced life sciences degree, preferably medical doctor, or equivalent through experience
Experience
Minimum of 3-5 years of experience in a (general) healthcare organization, especially in Clinical Development and/or Medical Affairs and/or Pharmacovigilance
Preferably in-depth experience in drug development process across different stages, especially clinical development and clinical operations
Experience in development and authorship of complex PV documents
Experience of leading and contributing to teams across cultures and geographies (if applicable)
Experience of working across and building effective working relationships between functions
Skills & Competencies
Strong organizational and process management skills
Strong financial reporting experience and skills and understanding of business systems
Demonstrated project management capability
Highly effective communicator with strong influencing ability and communication skills
Demonstrated ability to function effectively and successfully in a complex global and multicultural environment
Ability to take personal responsibility and accountability
Organized, able to multi-task effectively
Knowledge in Pharmacovigilance relevant regulations
Languages
Fluency in English (written and verbal communication skills)
Personal Attributes
Collaborative, team-oriented, flexible
Período de aplicación: 29 Julio al 12 Ag
📌 Pharmacovigilance Country Head PE/VE (Lima)
🏢 Bayer
📍 Lima